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The Cochrane Database of Systematic... Aug 2015Optic neuritis is an inflammatory disease of the optic nerve. It usually presents with an abrupt loss of vision and recovery of vision is almost never complete. It... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Optic neuritis is an inflammatory disease of the optic nerve. It usually presents with an abrupt loss of vision and recovery of vision is almost never complete. It occurs more commonly in women than in men. Closely linked in pathogenesis, optic neuritis may be the initial manifestation for multiple sclerosis. In some people, no underlying cause can be found.
OBJECTIVES
The objective of this review was to assess the effects of corticosteroids on visual recovery in eyes with acute optic neuritis.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2015, Issue 4), MEDLINE (January 1950 to April 2015), EMBASE (January 1980 to April 2015), Latin American and Caribbean Health Sciences Literature (LILACS) (January 1982 to April 2015), PubMed (January 1946 to April 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The metaRegister of Controlled Trials (mRCT) was last searched on 6 March 2014. The electronic databases were last searched on 7 April 2015. We also searched reference lists of identified trial reports for additional trials.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that evaluated systemic corticosteroids, in any form, dose or route of administration, in people with acute optic neuritis.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included six RCTs with a total of 750 participants. Each trial was conducted in a different country: Denmark, Germany, India, Japan, UK, and United States. Additionally, we identified two ongoing trials not due to be completed until 2016. Among the six trials included in this review, we judged one to be at high risk of bias. The remaining five trials were judged to be at either low or uncertain risk of biases.Five trials compared only two intervention groups and one trial had a three-arm comparison of oral corticosteroids or intravenous corticosteroids with placebo. Of the five trials with only two intervention groups, two trials compared oral corticosteroids versus placebo, two trials compared intravenous corticosteroids with placebo, and one trial compared intravenous dexamethasone with intravenous methylprednisolone plus oral prednisolone.Three trials evaluating oral corticosteroids used varying doses of corticosteroids versus placebo. In the meta-analyses to assess visual acuity, the risk ratio (RR) was 1.00 (95% confidence interval (CI) 0.82 to 1.23; participants = 398) at one month; 0.92 (95% CI 0.77 to 1.11; participants = 355) at six months; and 0.93 (95% CI 0.70 to 1.24; participants = 368) at one year. In the meta-analyses of two trials evaluating corticosteroids with total dose greater than 3000 mg administered intravenously, the RR of normal visual acuity (defined as 20/20 Snellen fraction or equivalent) in the intravenous corticosteroids group compared with the placebo group was 1.05 (95% CI 0.88 to 1.26; participants = 346) at six months. The RR of contrast sensitivity in the normal range for the same comparison was 1.11 (95% CI 0.92 to 1.33; participants = 346) at six months follow-up. The RR of normal visual field for this comparison was 1.08 (95% CI 0.96 to 1.21; 346 participants) at six months; and 1.01 (95% CI 0.86 to 1.19; participants = 316) at one year. Four trials reported adverse events primarily related to gastrointestinal symptoms and sleep disturbance; one trial reported minor adverse event of acne.
AUTHORS' CONCLUSIONS
There is no conclusive evidence of benefit in terms of recovery to normal visual acuity, visual field or contrast sensitivity six months after initiation with either intravenous or oral corticosteroids at the doses evaluated in trials included in this review.
Topics: Acute Disease; Administration, Oral; Anti-Inflammatory Agents; Contrast Sensitivity; Dexamethasone; Female; Glucocorticoids; Humans; Injections, Intravenous; Male; Methylprednisolone; Optic Neuritis; Prednisone; Randomized Controlled Trials as Topic; Visual Acuity
PubMed: 26273799
DOI: 10.1002/14651858.CD001430.pub4 -
Ophthalmology. Retina Oct 2023To compare outcomes of scleral buckle (SB), pars plana vitrectomy (PPV), and combined PPV-SB to treat rhegmatogenous retinal detachments (RRDs) with inferior retinal... (Meta-Analysis)
Meta-Analysis Review
TOPIC
To compare outcomes of scleral buckle (SB), pars plana vitrectomy (PPV), and combined PPV-SB to treat rhegmatogenous retinal detachments (RRDs) with inferior retinal breaks (IRBs).
CLINICAL RELEVANCE
Rhegmatogenous retinal detachments with IRBs are not uncommon; their management is challenging with higher risk of failure. There is no consensus about their treatment, specifically whether SB, PPV, or PPV-SB should be performed.
METHODS
Systematic review and meta-analysis. Randomized controlled trials, case-control, and prospective/retrospective series (if n > 50) in English were eligible. Medline, Embase, and Cochrane databases were searched up to January 23, 2023. Standard systematic review methods were followed. The following outcomes at 3 (± 1) and 12 (± 3) months were evaluated: number of eyes with retinal reattachment after ≥ 1 surgeries, change in best-corrected visual acuity from preoperative to postoperative levels, and number of eyes with improvement of > 10 and > 15 ETDRS letters after surgery. Authors of eligible studies were asked for individual participant data (IPD) and IPD meta-analysis was undertaken. Risk of bias was assessed using National Institutes of Health study quality assessment tools. This study was registered prospectively in PROSPERO (CRD42019145626).
RESULTS
A total of 542 studies were identified: 15 were eligible and included and 60% were retrospective. Individual participant data was obtained from 8 studies (1017 eyes). Given that only 26 patients had received SB alone, these data were not considered in the analysis. There was no evidence for differences between treatment groups (PPV versus PPV-SB) in the probability of having a flat retina at 3 or 12 months postoperatively after 1 (P = 0.067; odds ratio [OR], 0.47; P = 0.408; OR 2.55; respectively) or > 1 (OR, 0.54; P = 0.21; OR, 0.89; P = 0.926; respectively) surgery. Pars plana vitrectomy-SB showed less improvement in vision postoperatively at 3 months (estimate, 0.18; 95% confidence interval, 0.01-0.35; P = 0.044), but this difference was no longer observed at 12 months (estimate, -0.07; 95% confidence interval, -0.27, 0.13; P = 0.479).
CONCLUSION
Available evidence suggests a lack of benefit of adding SB to PPV to treat RRDs with IRBs. Evidence, however, comes mainly from retrospective series and, thus, despite the large number of eyes included, should be interpreted with caution. Further research is needed.
FINANCIAL DISCLOSURE(S)
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Topics: Humans; Retinal Detachment; Vitrectomy; Retrospective Studies; Prospective Studies; Visual Acuity; Retinal Perforations
PubMed: 37187441
DOI: 10.1016/j.oret.2023.05.006 -
The Cochrane Database of Systematic... Aug 2016Age-related macular degeneration (AMD) is a progressive, late-onset disorder of the macula affecting central vision. It is the leading cause of blindness in people over... (Review)
Review
BACKGROUND
Age-related macular degeneration (AMD) is a progressive, late-onset disorder of the macula affecting central vision. It is the leading cause of blindness in people over 65 years in industrialized countries. Recent epidemiologic, genetic, and pathological evidence has shown that AMD shares a number of risk factors with atherosclerosis, leading to the hypothesis that statins may exert protective effects in AMD.
OBJECTIVES
The objective of this review was to examine the effectiveness of statins compared with other treatments, no treatment, or placebo in delaying the onset and progression of AMD.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to March 2016), EMBASE (January 1980 to March 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to March 2016), PubMed (January 1946 to March 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 5 June 2014), ClinicalTrials.gov (www.clinicaltrials.gov), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 31 March 2016.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-randomized trials that compared statins with other treatments, no treatment, or placebo in people who were diagnosed as having the early stages of AMD.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two review authors independently evaluated the search results against the selection criteria, abstracted data, and assessed risk of bias. We did not perform meta-analysis due to heterogeneity in the interventions and outcomes between the included studies.
MAIN RESULTS
Two RCTs with a total of 144 participants met the selection criteria. Both trials compared simvastatin versus placebo in older people (older than 50 or 60 years) with high risk of developing AMD (drusen present on examination). Overall, we judged the quality of the evidence to be low, as we downgraded all outcomes due to limitations in the designs of the trials and insufficient outcome reporting. The larger trial, with 114 participants, was conducted in Australia and used a higher dose (40 mg daily) of simvastatin for three years. Participants and study personnel in this trial were adequately masked, however data were missing for 30% of participants at three years' follow-up. The smaller trial, with 30 participants, was conducted in Italy and used a lower dose (20 mg) of simvastatin for three months. This trial reported insufficient details to assess the risk of bias.Neither trial reported data for change in visual acuity. Low-quality evidence from the smaller trial, with 30 participants, did not show a statistically significant difference between the simvastatin and placebo groups in visual acuity values at three months of treatment (decimal visual acuity 0.21 ± 0.56 in simvastatin group and 0.19 ± 0.40 in placebo group) or 45 days after the completion of treatment (decimal visual acuity 0.20 ± 0.50 in simvastatin group and 0.19 ± 0.48 in placebo group). The lack of a difference in visual acuity was not explained by lens or retina status, which remained unchanged during and after the treatment period for both groups.Preliminary analyses of 42 participants who had completed 12 months' follow-up in the larger trial did not show a statistically significant difference between simvastatin and the placebo groups for visual acuity, drusen score, or visual function (effect estimates and confidence intervals were not available). Complete data for these outcomes at three years' follow-up were not reported. At three years, low-quality evidence showed an effect of simvastatin in slowing progression of AMD compared with placebo to be uncertain (odds ratio 0.51, 95% confidence interval 0.23 to 1.09).One trial did not report adverse outcomes. The second trial reported no difference between groups in terms of adverse events such as death, muscle aches, and acute hepatitis.
AUTHORS' CONCLUSIONS
Evidence from currently available RCTs is insufficient to conclude that statins have a role in preventing or delaying the onset or progression of AMD.
Topics: Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Macular Degeneration; Male; Middle Aged; Randomized Controlled Trials as Topic; Simvastatin; Visual Acuity
PubMed: 27490232
DOI: 10.1002/14651858.CD006927.pub5 -
Eye (London, England) Jan 2020This article is a systematic review of evidence regarding the impact of different lighting conditions on the vision and quality of life (QoL) of people with primary... (Review)
Review
This article is a systematic review of evidence regarding the impact of different lighting conditions on the vision and quality of life (QoL) of people with primary open-angle glaucoma (POAG). A systematic literature search was carried out using CINAHL, MEDLINE, PsycARTICLES, PsycINFO, Embase, and Ovid Nursing Database for studies: published up to April 2019; including people diagnosed with POAG; and assessing visual function or QoL in response to changing lighting/luminance levels or glare. Two researchers independently screened studies for eligibility. Data were extracted from eligible studies regarding study design, participant characteristics, outcomes, and results. Quality of included studies was critically appraised. Of 8437 studies, 56 eligible studies were included. Studies investigated the effects of lighting on the following domains among people with POAG: QoL (18/56), psychophysical measures (16/56), functional vision (10/56), activities of daily living (10/56), and qualitative findings (2/56). POAG negatively affects low-luminance contrast sensitivity, glare symptoms, and dark adaptation time and extent. In vision-related QoL questionnaires, people with POAG report problems with lighting, glare, and dark adaptation more frequently than any other domain. These problems worsen with progressing visual field loss. Early-stage POAG patients experience significantly more difficulties in low-luminance or changing lighting conditions than age-matched controls (AMCs), challenging perceptions of early-stage POAG as asymptomatic. However, performance-based studies seldom show significant differences between POAG participants and AMCs on tasks simulating daily activities under non-optimal lighting conditions. Further research with larger samples is required to optimise ambient and task-oriented lighting that can support patients' adaptation to POAG.
Topics: Activities of Daily Living; Glaucoma; Glaucoma, Open-Angle; Humans; Lighting; Quality of Life; Visual Acuity
PubMed: 31822854
DOI: 10.1038/s41433-019-0679-5 -
Advances in Therapy Mar 2017Neovascular age-related macular degeneration (nAMD) is a chronic eye condition that causes severe deterioration of vision and ultimately blindness. Two vascular... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Neovascular age-related macular degeneration (nAMD) is a chronic eye condition that causes severe deterioration of vision and ultimately blindness. Two vascular endothelial growth factor inhibitors are approved for nAMD treatment in Europe: ranibizumab and aflibercept. The European license for ranibizumab was updated with an individualized "treat and extend" (T&E) regimen, which involves more proactive treatment based on changes in best corrected visual acuity (BCVA) and/or anatomical outcomes. The aim of this publication is to compare the efficacy of the ranibizumab T&E regimen with other approved dosing regimens for nAMD on the basis of outcomes identified from a systematic review and subsequent NMA.
METHODS
Following a systematic search of publications, to identify relevant studies, a repeated-measures network meta-analysis (NMA) was performed to estimate the relative effectiveness of ranibizumab T&E versus approved dosing regimens of ranibizumab and aflibercept. The analysis focused on licensed treatment regimens for nAMD. We examined mean change from baseline in BCVA on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
RESULTS
The systematic literature review identified 22,949 records, of which 23 studies were included in the NMA. At 12 months, the ranibizumab T&E dosing regimen vs ranibizumab pro re nata (PRN) was associated with small differences in change in BCVA, between 1.86 letter gain at 12 months and 2.35 letter gain at 24 months. A similar difference was observed in the aflibercept dosing regimen versus ranibizumab T&E ; 1.94 letter gain at 12 months and 3.31 letter gain at 24 months. All doses of ranibizumab and aflibercept showed similar effectiveness, and the differences between treatment options were not significant.
CONCLUSION
This study used novel repeated-measures NMA to synthesize efficacy results when treatment effects were reported at multiple follow-up times. This repeated-measures NMA suggests that treating patients with the ranibizumab T&E regimen yields similar effectiveness compared to other approved ranibizumab and aflibercept dosing regimens for nAMD treatment.
FUNDING
Novartis Pharmaceuticals UK Ltd, Surrey, UK.
Topics: Aged; Angiogenesis Inhibitors; Drug Monitoring; Europe; Humans; Ranibizumab; Receptors, Vascular Endothelial Growth Factor; Recombinant Fusion Proteins; Treatment Outcome; Vascular Endothelial Growth Factor A; Visual Acuity; Wet Macular Degeneration
PubMed: 28188433
DOI: 10.1007/s12325-017-0484-0 -
New Microbes and New Infections Jan 2023In a broad sense, are a group of microorganisms that can be transmitted mechanically or biologically to animals and humans. Rickettsioses are associated with hematic... (Review)
Review
In a broad sense, are a group of microorganisms that can be transmitted mechanically or biologically to animals and humans. Rickettsioses are associated with hematic manifestations. Its prevalence in humans, dogs and other animals has been widely explored, but not in equine species. To determine the prevalence of infection in horses. A systematic review of the literature was carried out in five databases for the proportion of horses infected with , defined by molecular and immunological techniques. A meta-analysis was performed using a random-effects model to calculate the pooled prevalence and 95% confidence intervals (CI). The Cochran's Q test and the I statistic were used to assess the between-study-heterogeneity. The pooled prevalence of in equines was 37.0% (95% CI: 26.0%-47.0%), with significant heterogeneity among studies (I = 98.12%). In the subgroup analysis, the prevalence of in horses was found to be 24.0% (95%CI: 10.0%-41.0%) for IFI, 47.0% (95%CI: 30.0%-64.0%) for IFA, 14.0% (95%CI: 11.0%-17.0%) for IFAT and 39.0% (95%CI: 0.0%-95.0%) for PCR. There was a high prevalence of among horses, with some of the species being zoonotic, with their corresponding implications for humans, which increasingly are in close contact with equines, particularly horses and their ticks, posing a risk for spillover and transmission.
PubMed: 36632173
DOI: 10.1016/j.nmni.2022.101068 -
JMIR MHealth and UHealth Feb 2022Vision impairments (VIs) and blindness are major global public health issues. A visual acuity (VA) test is one of the most crucial standard psychophysical tests of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vision impairments (VIs) and blindness are major global public health issues. A visual acuity (VA) test is one of the most crucial standard psychophysical tests of visual function and has been widely used in a broad range of health care domains, especially in many clinical settings. In recent years, there has been increasing research on mobile app-based VA assessment designed to allow people to test their VA at any time and any location.
OBJECTIVE
The goal of the review was to assess the accuracy and reliability of using mobile VA measurement apps.
METHODS
We searched PubMed, Embase, Cochrane Library, and Google Scholar for relevant articles on mobile apps for VA assessment published between January 1, 2008, and July 1, 2020. Two researchers independently inspected and selected relevant studies. Eventually, we included 22 studies that assessed tablet or smartphone apps for VA measurement. We then analyzed sensitivity, specificity, and accuracy in the 6 papers we found through a meta-analysis.
RESULTS
Most of the 22 selected studies can be considered of high quality based on the Quality Assessment of Diagnostic Accuracy Studies-2. In a meta-analysis of 6 studies involving 24,284 participants, we categorized the studies based on the age groups of the study participants (ie, aged 3-5 years, aged 6-22 years, and aged 55 years and older), examiner (ie, professional and nonprofessional examiners), and the type of mobile devices (ie, smartphone, iPad). In the group aged 3 to 5 years, the pooled sensitivity for VA app tests versus clinical VA tests was 0.87 (95% CI 0.79-0.93; P=.39), and the pooled specificity was 0.78 (95% CI 0.70-0.85; P=.37). In the group aged 6 to 22 years, the pooled sensitivity for VA app tests versus clinical VA tests was 0.86 (95% CI 0.84-0.87; P<.001), and the pooled specificity for VA app tests versus clinical VA tests was 0.91 (95% CI 0.90-0.91; P=.27). In the group aged 55 years and older, the pooled sensitivity for VA app tests versus clinical VA tests was 0.85 (95% CI 0.55-0.98), and the pooled specificity for VA app tests versus clinical VA tests was 0.98 (95% CI 0.95-0.99). We found that the nonprofessional examiner group (AUC 0.93) had higher accuracy than the professional examiner group (AUC 0.87). In the iPad-based group, the pooled sensitivity for VA app tests versus clinical VA tests was 0.86, and the pooled specificity was 0.79. In the smartphone-based group, the pooled sensitivity for VA app tests versus clinical VA tests was 0.86 (P<.001), and the pooled specificity for VA app tests versus clinical VA tests was 0.91 (P<.001).
CONCLUSIONS
In this study, we conducted a comprehensive review of the research on existing mobile apps for VA tests to investigate their diagnostic value and limitations. Evidence gained from this study suggests that mobile app-based VA tests can be useful for on-demand VI detection.
Topics: Adolescent; Adult; Child; Child, Preschool; Computers, Handheld; Humans; Middle Aged; Mobile Applications; Reproducibility of Results; Smartphone; Visual Acuity; Young Adult
PubMed: 35156935
DOI: 10.2196/26275 -
Journal of Infection and Public Health Jul 2024Mpox is a zoonotic disease that became epidemic in multiple countries in 2022. There is a lack of published systematic reviews on natural animal infection due to Mpox.... (Meta-Analysis)
Meta-Analysis Review
Mpox is a zoonotic disease that became epidemic in multiple countries in 2022. There is a lack of published systematic reviews on natural animal infection due to Mpox. We performed a systematic literature review with meta-analysis to assess animal Mpox prevalence. We performed a random-effects model meta-analysis to calculate the pooled prevalence and 95% confidence interval (95%CI) for prevalence studies. After the screening, 15 reports were selected for full-text assessment and included in qualitative and quantitative analyses. Ten reports assessed Mpox infection by molecular or serological tests (n = 2680), yielding a pooled prevalence of 16.0% (95%CI: 3.0-29.0%) for non-human primates; 8.0% (95%CI: 4.0-12.0%) for rodents and 1.0% (95%CI: 0.0-3.0%) for shrews. Further studies in other animals are required to define the extent and importance of natural infection due to Mpox. These findings have implications for public human and animal health. OneHealth approach is critical for prevention and control.
Topics: Animals; Zoonoses; Prevalence; Mpox (monkeypox); Rodentia; Humans; Shrews; Primates
PubMed: 38820901
DOI: 10.1016/j.jiph.2024.04.015 -
Journal of Clinical Medicine Nov 2023The purpose of the research project was to extensively review the efficacy and safety of a trehalose tear-substitute treatment in cases of dry eye disease (DED). A... (Review)
Review
The purpose of the research project was to extensively review the efficacy and safety of a trehalose tear-substitute treatment in cases of dry eye disease (DED). A systematic review that included only full-length randomized controlled studies (RCTs) reporting the effects of trehalose tear-substitute treatment in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The search period included papers published before 8 August 2023. The Cochrane risk-of-bias tool was used to analyze the quality of the studies selected. A total of 10 RCTs were included in this systematic review. Trehalose tear-substitute treatments achieved a higher improvement than did control group interventions in all reported variables. The mean differences between both groups were in favor of trehalose, and were as follows: ocular surface disease index (OSDI) questionnaire score of -8.5 ± 7 points, tear film breakup time (TBUT) of 1.9 ± 1 s, tear film thickness (TFT) of 0.25 ± 0.1 μm, tear meniscus height (TMH) of 0.02 ± 0.02 mm, Schirmer test (ST) of 0.8 ± 1.4 mm, corneal fluorescein staining (CFS) of -0.7 ± 0.1 points and visual acuity (VA) of 0.3 ± 2.1 letters. No adverse events after trehalose tear-substitute treatments were reported. Trehalose tear substitutes are a safe and effective treatment for DED. Therefore, trehalose tear substitutes should be recommended for patients with dry eye disease. In addition, there is specific evidence to support its use in the preoperative cataract surgery period.
PubMed: 38068353
DOI: 10.3390/jcm12237301 -
The Cochrane Database of Systematic... Oct 2017Symptomatic vitreomacular adhesion (sVMA) is a recognised cause of visual loss and by tradition has been managed by pars plana vitrectomy (PPV). A less invasive... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Symptomatic vitreomacular adhesion (sVMA) is a recognised cause of visual loss and by tradition has been managed by pars plana vitrectomy (PPV). A less invasive alternative to surgery in some people is enzymatic vitreolysis, using an intravitreal injection of ocriplasmin.
OBJECTIVES
To assess the efficacy and safety of ocriplasmin compared to no treatment, sham or placebo for the treatment of sVMA.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 1), MEDLINE Ovid (1946 to 24 February 2017), Embase Ovid (1947 to 24 February 2017), PubMed (1946 to 24 February 2017), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 24 February 2017, ClinicalTrials.gov (www.clinicaltrials.gov); searched 24 February 2017 and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 24 February 2017. We did not use any date or language restrictions in the electronic searches for trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of people with sVMA. The intervention was intravitreal ocriplasmin 125 μg injection, and this was compared to placebo or sham injection (control). Placebo was defined as a single intravitreal injection of 0.10 mL placebo with identical drug vehicle diluted with saline. A sham injection was defined as the syringe hub or blunt needle touching the conjunctiva to simulate an injection.
DATA COLLECTION AND ANALYSIS
Two authors independently selected relevant trials, assessed methodological quality and extracted data. We graded the certainty of the evidence using the GRADE approach.
MAIN RESULTS
This review included four RCTs conducted in Europe and the USA with a total of 932 eyes of 932 participants. Participants were 18 to 97 years of age, with evidence of focal vitreomacular adhesion (VMA) on optical coherence tomography (OCT) imaging, with a best corrected visual acuity (BCVA) of 20/25 or worse in the study eye and 20/400 or better in the fellow eye. The interventions compared were intravitreal ocriplasmin versus sham (two RCTs) or placebo (two RCTs) injection. Both sham and placebo injection were classified as the control group. The main outcome measures were assessed at 28 days and six months. Overall, we judged the studies to have a low or unclear risk of bias. All four RCTs were sponsored by the manufacturers of ocriplasmin.Compared with control, ocriplasmin treatment was more likely to result in VMA release within 28 days (risk ratio (RR) 3.46, 95% confidence interval (CI) 2.00 to 6.00; 859 eyes, 4 RCTs, high-certainty evidence). Approximately 97/1000 eyes will have VMA release within 28 days without treatment. An additional 237 eyes will have VMA release within 28 days for every 1000 eyes treated with ocriplasmin (95% CI 96 more to 482 more).Treatment with ocriplasmin was also more likely to result in macular hole closure (RR 2.87, 95% CI 1.50 to 5.51; 229 eyes, 3 RCTs, high-certainty evidence). Approximately 123/1000 eyes with macular holes will have closure with no treatment. An additional 231 eyes will have macular hole closure for every 1000 eyes treated with ocriplasmin (95% CI 62 more to 556 more).Eyes receiving ocriplasmin were also more likely to have complete posterior vitreous detachment (PVD) within 28 days (RR 2.94, 95% CI 1.39 to 6.24; 689 eyes, 3 RCTs, high-certainty evidence). Approximately 40/1000 eyes will have complete PVD within 28 days without treatment. An additional 78 eyes will have complete PVD within 28 days for every 1000 eyes treated with ocriplasmin (95% CI 16 more to 210 more).Eyes receiving ocriplasmin were more likely to achieve 3-line or greater improvement in BCVA at six months (RR 1.95, 95% CI 1.07 to 3.53; 674 eyes, 3 RCTs, moderate-certainty evidence). Approximately 61/1000 eyes will have a 3-line or greater improvement in BCVA at six months without treatment. An additional 58 eyes will have 3-line or greater improvement in BCVA at six months for every 1000 eyes treated with ocriplasmin (95% CI 9 more to 154 more).Receiving ocriplasmin also reduced the requirement for vitrectomy at six months (RR 0.67, 95% CI 0.50 to 0.91; 689 eyes, 3 RCTs, moderate-certainty evidence). Approximately 265/1000 eyes will require vitrectomy at six months without treatment and 87 fewer eyes will require vitrectomy for every 1000 eyes treated with ocriplasmin (95% CI 24 fewer to 132 fewer).Treatment with ocriplasmin resulted in a greater improvement in validated Visual Function Questionnaire form score at six months (mean improvement difference 2.7 points, 95% CI 0.8 to 4.6; 652 eyes, 2 RCTs, moderate-certainty evidence).Eyes receiving ocriplasmin were more likely to have an adverse event (RR 1.22, 95% CI 1.09 to 1.37, 909 eyes, 4 RCTs, moderate-certainty evidence). Approximately 571/1000 eyes will have an adverse event with sham or placebo injection and 106 more eyes will have an adverse event for every 1000 eyes treated with ocriplasmin (95% CI 52 more to 212 more).
AUTHORS' CONCLUSIONS
Evidence from a limited number of RCTs suggests that ocriplasmin is useful in the treatment of sVMA. However, up to 20% of eyes treated with ocriplasmin will still require additional treatment with PPV within six months. There were more ocular adverse events in eyes treated with ocriplasmin than control (sham or placebo injection) treatment. Many of these adverse events, particularly vitreous floaters and photopsia, are known to be associated with posterior vitreous detachment. At present however, there is minimal published long-term safety data on eyes treated with ocriplasmin. Further large RCTs comparing ocriplasmin with other management options for sVMA would be beneficial.
Topics: Adult; Aged; Aged, 80 and over; Fibrinolysin; Fibrinolytic Agents; Humans; Intravitreal Injections; Middle Aged; Peptide Fragments; Randomized Controlled Trials as Topic; Retinal Diseases; Time Factors; Tissue Adhesions; Visual Acuity; Vitrectomy; Vitreous Body; Vitreous Detachment
PubMed: 29040800
DOI: 10.1002/14651858.CD011874.pub2